A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
18. června 2018 aktualizováno: Pfizer
A Phase 1, Single-dose, Randomized, 4-treatment, 4-period Crossover, Placebo- And Positive-controlled, Double-blind (Open-label For Positive Control), Sponsor-open Study To Determine The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects.
This is conducted as part of standard drug development.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
44
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Connecticut
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New Haven, Connecticut, Spojené státy, 06511
- Pfizer New Haven Clinical Research Unit
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.
- History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.
- History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.
- Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: PF-04447943 low dose
25 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
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|
Experimentální: PF-04447943 high dose
100 mg of PF-04447943
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Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
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|
Komparátor placeba: Placebo
Matching placebo for PF-04447943
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Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
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Aktivní komparátor: Moxifloxacin
400 mg of moxifloxacin
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Single oral dose of moxifloxacin administered as tablet
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose
Časové okno: 0.5 hour post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
0.5 hour post-dose
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
Časové okno: 1 hour post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
1 hour post-dose
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
Časové okno: 2 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
2 hours post-dose
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
Časové okno: 3 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
3 hours post-dose
|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
Časové okno: 4 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
4 hours post-dose
|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
Časové okno: 8 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
8 hours post-dose
|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
Časové okno: 12 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
12 hours post-dose
|
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Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
Časové okno: 24 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
24 hours post-dose
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Časové okno: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
|
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
|
0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
|
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Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
Časové okno: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
|
Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
|
|
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
Časové okno: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
Časové okno: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics.
Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
|
0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
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Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
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Number of Participants With Physical Examination Abnormalities
Časové okno: Baseline (Pre-dose)
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Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Physical examination abnormalities were judged by the investigator.
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Baseline (Pre-dose)
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Number of Participants With Electrocardiogram (ECG) Abnormalities
Časové okno: Baseline up to 24 hours post-dose
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Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec).
Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.
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Baseline up to 24 hours post-dose
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Number of Participants With Vital Sign Abnormalities
Časové okno: Baseline (Pre-dose) up to 24 hours post-dose
|
Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.)
increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg.
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Baseline (Pre-dose) up to 24 hours post-dose
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Number of Participants With Laboratory Test Abnormalities
Časové okno: Baseline (Pre-dose) up to 24 hours post-dose
|
Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower
limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN,
lymphocyte, neutrophil<0.8*LLN,
>1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN,
white blood cell(WBC)<0.6*LLN,>1.5*ULN,
reticulocytes<0.5*LLN,>1.5*ULN;
bilirubin>1.5*ULN,
aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN,
protein, albumin<0.8*LLN,>1.2*ULN;
blood urea nitrogen, creatinine>1.3*ULN,
uric acid>1.2*ULN;
sodium<0.95*LLN,>1.05*ULN,
potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN;
glucose<0.6*LLN,
>1.5*ULN, HbA1c>1.3*ULN,
creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030,
pH<4.5,>8,
WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN;
cholesterol, triglycerides>1.3*ULN,
high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN.
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Baseline (Pre-dose) up to 24 hours post-dose
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Maximum Plasma Concentration (Cmax) of PF-04447943
Časové okno: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
|
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Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
Časové okno: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
|
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Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
Časové okno: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
Area under the plasma concentration-time from time zero to time of last measurable concentration.
Observed using the linear/log trapezoidal method.
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Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
29. června 2016
Primární dokončení (Aktuální)
20. října 2016
Dokončení studie (Aktuální)
20. října 2016
Termíny zápisu do studia
První předloženo
25. května 2016
První předloženo, které splnilo kritéria kontroly kvality
25. května 2016
První zveřejněno (Odhad)
30. května 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. prosince 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. června 2018
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- B0401018
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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